GB/T 40369-2021

Active

General rules for determination of immunochromatographic test strip

免疫层析试纸条检测通则

Standard Type
GBT
ICS
07.080
CCS
A40
Status
Active
Issue Date
2021-08-20
Implementation
2022-03-01
Centralized Committee
国家标准委
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

GB/T 40369-2021 specifies general rules for the design, operation, and result interpretation of immunochromatographic test strips, covering principles like sample application, reagent migration, and signal detection. It is applied in clinical diagnostics, food safety testing, and environmental monitoring to ensure consistent performance and reliability of lateral flow assays across laboratories and manufacturing settings. The standard provides a technical framework for evaluating strip sensitivity, specificity, and reproducibility in both qualitative and quantitative testing contexts.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.